An interventional study of Combined Aerobic Exercise and Resistance Training (AE + RT) and Cognitive Training (NeuropeakTM) in Mild Cognitive Impairment, sponsored by University of New Brunswick. Completed at 1 site in Canada. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by University of New Brunswick · Not applicable, Interventional, and Prevention
Background: Prevention of Alzheimer's Disease and Related Dementias (ADRDs) may be possible for persons with subjective (SCI) or mild cognitive impairment (MCI), or normal cognition and risk factors. Physical exercise and cognitive training have been shown to enhance cognitive function and mobility in MCI when delivered in a research facility. The feasibility of delivering interventions in the home of older adults at risk for developing ADRDs is not known. What preferences the participants have for these interventions are also unknown. The primary goals are: 1) assess feasibility of a home-based delivery of exercise and cognitive interventions 2) evaluate the relationship between participants' intervention preferences and adherence. Secondary objectives focus on cognition, frailty, mobility, sleep, diet and mental health.
Methods and analysis: SYNERGIC@Home is a randomized control trial (using a 2 x 2 factorial design) with a 16-week home-based intervention program of physical exercises with cognitive training. Sixty-four participants will be randomized in blocks of four: 1) combined exercise (aerobic and resistance) + cognitive training (NEUROPEAK™); 2) combined exercise + control cognitive training (web searching); 3) control exercise (balance and toning) + cognitive training; and 4) control exercise + control cognitive training. It will be implemented virtually through video conferencing. Baseline, 4- and 10-month post-intervention will include measures of cognition, frailty, mobility, sleep, diet, and psychological health. Feasibility outcomes include recruitment and retention. Preference will be used to determine the relationship between preference adherence. Secondary outcomes will evaluate the effect of the interventions on cognitive, mobility, and general well-being.
BACKGROUND: Nearly half a million Canadians live with Alzheimer's Disease and Related Dementias (ADRDs), and approximately one third of those cases could have been prevented with early intervention. Physical exercise and cognitive training are emerging interventions that have the potential to enhance cognitive function and mobility in older adults at risk for developing dementia. The SYNERGIC trial (SYNchronizing Exercises, Remedies in GaIt and Cognition), a large multi-site randomized control trial, showed promising preliminary data that individuals in an active exercise intervention combining aerobic exercise with progressive resistance training (AE+RT) and in a cognitive training program (NEUROPEAKTM) had better cognitive outcomes than a balance and toning control (BAT) intervention paired with a control cognitive intervention consisting of website searching and watching a simple video (WS+V). While these interventions were provided face to face in a research facility, little is known about the feasibility of delivering these multi-domain interventions at home in older adults at risk for developing ADRDs. Thus, the primary goal of the present trial-the SYNERGIC@Home trial-is to establish the feasibility of delivering a combined multimodal exercise and cognitive training intervention program for 16 weeks to 64 older adults at home using video-conferencing.
HYPOTHESIS: Based on the success of the SYNERGIC trial, we expect that SYNERGIC@Home will follow suit and yield high recruitment, retention, and adherence rates-particularly in light of the fact that SYNERGIC@Home eliminates any of the natural inconveniences of in person testing.
METHODS: SYNERGIC@Home is a randomized control trial (RCT) with a 16-week home-based intervention program of combined physical exercises with cognitive training. Sixty-four participants will be randomized to one of the following four arms: 1) combined exercise (AE+RT) + cognitive training (NEUROPEAKTM); 2) combined exercise (AE+RT) + control cognitive training (WS+V); 3) Control exercise (BAT) + cognitive training (NEUROPEAKTM) ; and 4) Control exercise (BAT) + control cognitive training (WS+V). SYNERGIC@Home will be implemented entirely virtually through video and phone conferencing. Baseline, immediate post-intervention follow-up, and 6-month post-intervention follow-up assessments will include measures of cognition, frailty, mobility, sleep, diet, and psychological health. For primary feasibility objectives, we will obtain measures of recruitment and retention rates. For primary analytic objectives, we will examine the distribution of preference ratings and determine if there is a relationship between preference for a given intervention and subsequent adherence. A series of secondary analytic outcomes examining the potential effect of the individual and combined interventions on cognitive, mobility, and general well-being will be measured at both baseline and follow-up. If we find a relatively equal split in sex our sample, we will conduct gender-based analyses as additional, exploratory research.
EXPECTED RESULTS AND DISCUSSION: The SYNERGIC@Home trial will establish the feasibility of a combined multimodal intervention program delivered at home in older adults. Similarly, it will estimate the frequency and strength of participant preference for different interventions and delineate the relationship between intervention preference and subsequent adherence. It will also build capacity for and pilot the delivery of multi-domain interventions using an entirely home-based protocol with individuals at risk for ADRDs. The SYNERGIC@Home trial will inform future larger scale studies on the feasibility and success of implementing home-based interventions for individuals at risk for ADRDs. Insights gained from this feasibility trial will be instrumental in developing various other at home, remote, and virtual intervention programs for community-dwelling older adults.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 60 is close to the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
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Being at risk of developing dementia:
Cognitively Intact with Risk Factors Group. Cognitively Intact based on COMPASS ND study2 definition (Table 1)) AND have a history of two or more risk factors for dementia, defined as the following (Table 1):
Exclusion Criteria:
Combined Aerobic Exercise and Resistance Training (AE + RT) + Cognitive Training (NeuropeakTM)
Behavioral: Combined Aerobic Exercise and Resistance Training (AE + RT) · Behavioral: Cognitive Training (NeuropeakTM)
Combined Aerobic Exercise and Resistance Training (AE + RT) + Control Cognitive Training of Website Searching and Video Watching (WS+V)
Behavioral: Combined Aerobic Exercise and Resistance Training (AE + RT) · Behavioral: Control Cognitive Training of Website Searching and Video Watching (WS+V)
Control Balance and Toning Exercise Training (BAT) + Cognitive Training (NeuropeakTM)
Behavioral: Cognitive Training (NeuropeakTM) · Behavioral: Control Balance and Toning Exercise Training (BAT)
Control Balance and Toning Exercise Training (BAT) + Control Cognitive Training of Website Searching and Video Watching (WS+V)
Behavioral: Control Cognitive Training of Website Searching and Video Watching (WS+V) · Behavioral: Control Balance and Toning Exercise Training (BAT)
AE + RT will be conducted via a video-conferencing platform under the direct supervision and coaching of a certified exercise physiologist with certification from the Canadian Society for Exercise Physiology (CSEP; or equivalent certification). These certified trainers will administer the exercise interventions in a one trainer to one participant ratio. AE + RT includes a set of warm up exercises, which will be completed in approximately 5 minutes, followed by a break. Next, 6 strength training exercises (that progressively increase in resistance intensity over time) will be completed followed by a break. Aerobic exercises that safely increase the participant's heart rate will follow for 30 minutes followed by a break and a set of cool down exercises for 5 minutes. In total the AE + RT exercise session is approximately 65 minutes.
NeuropeakTM is a program which will be completed by participants remotely using a tablet or computer. It consists of cognitive training including dual-task training that requires participants to maintain and prepare for many response alternatives (working memory) and to share attention between two concurrent tasks (divided attention). Difficulty of cognitive training is tailored to their individual functioning level. During each session, participants perform one of two different visuo-motor tasks, which include sets of visual stimuli (e.g., letters, numbers, animals, vehicles, fruits, celestial bodies) and respective hand-button correspondences (i.e., keys that are to be tapped on either the right or the left side of the screen). Participants are instructed to perform these tasks as fast as possible, while maintaining accuracy. Training also includes online feedback and a histogram of daily performance to encourage improvement. NeuropeakTM takes approximately 30 minutes to complete.
During the WS + V task, participants alternate between 2 different tasks (touristic searching using internet and video watching). For the touristic searching using internet, participants are required to find 3 hotels, 3 touristic places, and 3 restaurants of their own preference in a city assigned by the instructor (a new city will be selected each session). They will also need to include the respective addresses of those places on their log sheet. For the video watching task, participants watch a National Geographic video on YouTube selected by the instructor with a different video selected for each session. They will watch the video for 20 minutes and during the remaining 5 minutes they will answer the following questions on their log sheet: 1) What is the video about? 2) What is the most important information in your opinion? 3) Create a question based on the video and answer your own question. WS + V sessions take approximately 30 minutes to complete.
BAT exercises will be conducted via a video-conferencing platform under the direct supervision and coaching of a certified exercise physiologist with certification from the Canadian Society for Exercise Physiology (CSEP; or equivalent certification). These certified trainers will administer the exercise interventions in a one trainer to one participant ratio. BAT includes a set of warm up exercises, which will be completed in approximately 5 minutes, followed by a break. Next, 6 balance and toning exercises will be completed followed by a break. Stretching exercises will follow for 30 minutes followed by a break and a set of cool down exercises for 5 minutes. In total the BAT exercise session is approximately 65 minutes.
Intervention Adherence
Defined as the mean percent of all Intervention sessions attended of the 48 planned sessions per participant.
Time frame: Post-intervention at 4 months
Intervention Preference
The primary analytic goal of SYNERGIC@Home is to assess the relationship between participants' adherence to the interventions and their affinity for each intervention going into the trial. All participants will be given the Intervention Preference Questionnaire (IPQ) prior to implementation of the intervention
Time frame: Baseline
Recruitment Rate
Defined as the total percent of enrolled participants relative to number of people screened for eligibility.
Time frame: Through study completion, an average of 10 months
Retention Rate
Defined as the total percent of enrolled participants who continue throughout the trial and participate in outcomes assessments as follows: * Enrollment retention: of those enrolled participants, the % who complete immediate 4-month post intervention assessment, and; * Follow-up retention: of those who complete the immediate 4-month post intervention follow-up assessment, the % of participants who complete the 6-month post-intervention follow-up assessment at 10-months.
Time frame: Through study completion, an average of 10 months
Assessment Tolerability
Defined as total percent of participants not voluntarily dropping out during baseline or between baseline assessment and prior to allocation to intervention group.
Time frame: Baseline
Trial Experience
Trial experience is defined as participants' qualitative responses to semi-structured open-ended questions aimed at providing insights on their overall trial experience within the context of the Kirkland evaluation framework.
Time frame: 10 months follow-up
Adverse Events
Frequency cross-tabulation of AE severity versus AE relation to trial.
Time frame: Monitored from start of study until end of study
Height
This measurement will be done at home and self-reported.
Time frame: Baseline
Data Loss
Defined as data lost due to technical failures, personnel errors or participant non-compliance
Time frame: Through study completion, an average of 10 months
Weight
This measurement will done at home and self-reported.
Time frame: Baseline
Sex
This measurement will be self-reported.
Time frame: Baseline
Age
This measurement will be self-reported.
Time frame: Baseline
Change in Hip Circumference
This measurement will be done at home and self-reported.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Neck Circumference
This measurement will be done at home and self-reported.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in waist circumference
This measurement will be done at home and self-reported.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in blood pressure
Measured with a provided blood pressure cuff. Reported systolic/diastolic.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in heart rate
Measured with a provided blood pressure cuff. Reported in beats/minute.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Medications
This measurement will be self-reported.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Chronic Diseases
This measurement will be self-reported and will be monitored throughout the trial
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in fall history
Falls will be recorded throughout the trial, in which participants will be provided with a falls calendars, on which they will record any falls that have occurred, and the research team will collect them monthly.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Health Status and Self-Perception
Participants will answer questions on their self-perception of their health status
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Constant Fatigue
Participants will answer questions on fatigue.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Falls and Balance
Participants will answer questions on falls and balance
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Vision
Participants will answer questions on their vision
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Hearing
Participants will answer questions on their hearing
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Nutrition
Participants will answer questions on their nutrition.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Sleep
Participants will answer questions on their sleep.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Mayo Fluctuation Scale
Participants will answer questions on how they feel during a day. Scores range between 0 and 4 with higher scores meaning a worse outcome.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Telephone Cognitive Screen (TCogS)
is a widely used tool that measures cognitive function in older individuals. The telephone version of the CogS has been standardized and will be administered via video conferencing. It consists of a 26-point assessment that measures orientation, registration, attention and calculation, recall, and language
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Clinical Dementia Rating Scale (CDR)
The CDR is a validated 5-point composite scale used in longitudinal Alzheimer's Disease (AD) research to characterize cognitive and global function performance applicable to AD and related dementias.61 Information is obtained through a semi-structured interview of the patient and a reliable informant or collateral source (e.g. family member).
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in remote version of the Montreal Cognitive Assessment (MoCA)
The Full MoCA via Audio-Visual Conference consists of a 30-point test assessing the following items: short term memory recall, visuospatial abilities, executive functioning, phonemic fluency, verbal abstraction, attention, concentration, working memory, language, and orientation.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Lawton-Brody Instrumental Activities of Daily Living (IADL) scale
measures participant's ability to engage in instrumental activities of daily living via questionnaire assessing activities such as preparing meals and managing personal finances
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in ADAS-Cog Immediate Word Recall
Participants are presented with 10 high imagery words and are given three trials to learn and recall them.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in ADAS-Cog Delayed Word Recall
Participants are asked to recall the 10 high imagery words presented during the immediate word recall task after a delay of approximately 5 to 10 minutes.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in ADAS-Cog Orientation
Participants are asked 8 questions pertaining to their identity, the place, and the time.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Cognitive Functional Composite 2 (CFC-2)
The CFC-2 is a collective of different test which consists of the ADAS-Cog Immediate Word Recall, ADAS-Cog Delayed Word Recall, ADAS-Cog Orientation, Clinical Dementia Rating Sum of Boxes (CDR-SB) Cognitive portion, and the Functional Activities Questionnaire.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Functional Activities Questionnaire
It measures participant's ability to engage in instrumental activities of daily living via questionnaire assessing activities such as preparing meals and managing personal finances
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Oral Trail Making Test (TMT) A
The Oral Trail Making Test (TMT) A \& B is a two-part test that assesses attention speed, and mental flexibility and has been widely used in clinical settings for assessing deficits in attention and executive functioning.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Oral Trail Making Test (TMT) B
The Oral Trail Making Test (TMT) A \& B is a two-part test that assesses attention speed, and mental flexibility and has been widely used in clinical settings for assessing deficits in attention and executive functioning.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in 15-item Boston Naming Test (BNT)
The Boston Naming Test (BNT) assesses visual confrontational naming and asks participants to name simple line drawings of objects.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Logical Memory I
Logical Memory I \& II (Story A) from the Wechsler memory scale assesses memory and free recall. Scores range between 0 and 25 with higher scores meaning a better outcome.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Logical Memory II
Logical Memory I \& II (Story A) from the Wechsler memory scale assesses memory and free recall. Scores range between 0 and 25 with higher scores meaning a better outcome.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in ADAS-Cog Word Recognition
Participants are presented with a list of 12 words and are then asked to identify the words among a list of distractor words.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in The Delis-Kaplan Executive Function System (DKEFS) phonemic fluency test
The Delis-Kaplan Executive Function System (DKEFS) phonemic fluency test measures phonemic verbal fluency.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in The Delis-Kaplan Executive Function System (DKEFS) semantic fluency test
The Delis-Kaplan Executive Function System (DKEFS) semantic fluency test measures speed and flexibility of verbal thought.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Digit Span Backward Test
The digit span test is an auditory attention task, in which participants are asked to recall a series of numbers forward and backward.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Oral version of the Digit Symbol Modalities Test
This is a timed task that gives participants 120 seconds to orally match geometric figures with specific numbers according to a defined key (specifying which symbols are assigned to which numbers) that is provided at the top of the stimulus page.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in 18-item Pittsburgh Sleep Quality Index (PSQI-18)
This is a 18-item questionnaire to help evaluate a participants sleep quality
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Work and Sleep Diary (WSD)
A self reported work and sleep diary to track activity and sleep during the assessments.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in 14-item Mediterranean Diet Assessment (MDA-14)
A 14-item questionnaire to help evaluate a participants diet.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Eating Pattern Self-Assessment
The Eating Pattern Self-Assessment is a tool used for participants to provide a self-report on their eating patterns.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Questionnaire for Vitamin D intake
A questionnaire to determine a participant's intake of Vitamin D.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Physical Activity Scale for the Elderly (PASE)
A questionnaire to assess a participants activity level. Scores range from 0 to 400+ with higher scores meaning a better outcome.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Life Space Questionnaire (LSQ)
A questionnaire to assess a participant's mobility ability.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Clinical Frailty Scale (CFS)
This assessment will be performed by the Clinical Research Coordinator/nurse using the 9 point CFS instrument. This will allow for a determination of the clinical frailty of the participants. Scores range between 1 and 9 with higher scores meaning a worse outcome.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Short Form quality of life questionnaire (SF-36)
A 36-item questionnaire that evaluates different aspects of quality of life.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
COVID-19 Questionnaire
A questionnaire that assesses a participants experience with the current COVID-19 pandemic. Scores range from 10-40 when self reported or 8-33 when reported by a study partner.
Time frame: Baseline
Change in Generalized Anxiety Disorder 7 (GAD 7)
A questionnaire to establish a participant's experience with anxiety
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Geriatric Depression Scale (GDS-30)
A questionnaire to establish a participant's experience with depression
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Short Test of Functional Health Literacy in Adults (STOFHLA)
Health Literacy will be assessed using the abbreviated version of the Test of Functional Health Literacy in Adults (TOFHLA).The short version, STOFHLA, consists of 2 prose passages and 4 numeracy items.
Time frame: Baseline
Change in Functional Assessment of Currently Employed Technology Scale (FACETS)
The FACETS is a 10-item questionnaire with possible responses falling on a Likert-type scale, and higher scores indicating more frequent use of technology domains.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in seated dual task
Participants will be asked to name as many animals as they are able to, count backwards by 1's, and count backwards by 7's while seated.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in single-task gait
Their gait velocity will be measured 3 times. Gait variability of spatial and temporal gait variables (stride time, stride length, double support time and step width) will be measured and the coefficient of variation calculated (CV = (standard deviation / mean) x 100).
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in dual-task gait
Participants will perform three walks, once each under the following dual-task conditions: walking while naming animals, counting backwards from 100 by 1's, and counting backwards from 100 by 7's.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Change in Sit to Stand Test (STST) performance
Participants will be asked to sit and stand, from a chair, repetitively for 60 seconds.
Time frame: Baseline, post-intervention at 4 months, and follow-up at 10 months
Biomarkers of Alzhiemer's Disease and Related Diseases
A saliva sample will be taken to get a Polygenic Hazard Score is derived from a panel of 31 single nucleotide polymorphisms. The genetic content known as DNA, or deoxyribonucleic acid, will be analyzed in order to learn about genetic information that may increase a person's risk for developing dementia. This test is part of the overall outcome measure and is not a diagnostic test. Study participants will not receive results of this test. This test is not currently a standard of normal clinical care and is still under research to determine its utility in clinical practice.
Time frame: Post intervention, at 8 months
Plan to share: Yes — Deidentified IPD will be stored on a secure server called LORIS (Longitudinal Online Research and Imaging System) at the McGill Centre for Integrative Neuroscience, McGill University, Montreal, Quebec.
Supporting information: Study protocol
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University of New Brunswick